Electrical Vestibular Nerve Stimulation (VeNS) As a Treatment for PTSD

Neurovalens

Status: Completed

Conditions: Post Traumatic Stress Disorder

Treatments: Device: Sham device; Device: Modius Spero active device

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05242367

MS003

Details and patient eligibility

About

Trial title: A Randomized, Double Blind Sham Controlled Clinical Trial to Evaluate the Efficacy of Electrical Vestibular Nerve Stimulation (VeNS), Compared to a Sham Control for Treatment of PTSD

The aim of this study: To better evaluate the efficacy of non-invasive electrical vestibular nerve stimulation (VeNS) as a method of treating PTSD, as compared to a sham control.

Allocation: Randomized to either active device or control device usage.

Endpoint classification: Efficacy Study Intervention Model: Parallel Assignment in 1:1 active to control allocation

Sample size: The aim is to recruit a total of up to 400 participants. The study will last 12 weeks in total for each subject.

Enrollment: 381 patients

Sex: All

Ages: 22 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent
• Diagnosed PTSD by a medical practitioner
• Post-Traumatic Checklist (PCL-5) score or 31 or above
• Eligibility confirmed via the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
• Male or female, age ≥ 22 years and ≤ 80 years at the time of signing informed consent
• Ability and willingness to complete all study visits and procedures, including completion of mental health questionnaires
• Ability and willingness to adhere to 30 minutes usage of the device daily for the duration of the trial
• Agreement not to start any new PTSD, mental health, or insomnia medications for the duration of the trial and/or to inform the study team if intending on starting any new PTSD, mental health, or insomnia medications
• Agreement not to change any PTSD specific treatments for the duration of the trial e.g cognitive processing therapy
• Agreement not to undergo any significant lifestyle changes that may affect sleep (e.g. excessive exercise, sleep interventions etc.) for the duration of the trial
• Agreement not to use sleep trackers (e.g. Fitbit) for the duration of the trial
• Agreement not to travel across different time zones for the duration of the trial
• Access to Wi-Fi (for app to be able to upload usage data)
• Access to computer, laptop, iPad or tablet (to conduct remote study visits and complete study questionnaires remotely)
• Screening review by PTSD physician (study PI)
• Willingness to download and use a video platform (e.g Zoom) to conduct remote study visits
• Willingness to engage weekly with your Clinical Trial Mentor (CTM)

Exclusion criteria

• History of skin breakdown, eczema, or other dermatological condition (e.g., psoriasis) affecting the skin behind the ears
• History of severe tinnitus or vertigo
• History or presence of malignancy within the last year
• Use of beta-blockers within 1 month of starting the study
• History of chronic viral infection that causes vestibular neuropathy (e.g., hepatitis or HIV)
• Use of antihistamines
• A history of stroke or severe head injury as defined by a head injury that required a craniotomy or endotracheal intubation (in case this damaged the neurological pathways involved in vestibular stimulation)
• Taking H2-receptor antagonist medication
• Presence of permanently implanted battery powered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator etc.)
• Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method
• Diagnosis of epilepsy
• Diagnosis of active migraines
• Previous use of Modius device
• Participation in other research studies sponsored by Neurovalens
• Participation in any other PTSD studies
• Not fluent in English language
• Have a member of the same household who is currently participating in this study
• Failure to agree to use of device daily during study participation
• Any other medical condition, or medication use, that in the opinion of the PI is likely to make the subject refractory to VeNS.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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381 participants in 2 patient groups

Active VeNS

Active Comparator group

Description:

The active device utilizes a technology termed vestibular nerve stimulation (VeNS). The device will be placed on the head in a manner analogous to headphones and will deliver a small electrical current to the skin behind the ears, over the mastoid processes. Participants will be advised to use the device at home for 30 minutes per day.

Treatment:

Device: Modius Spero active device

Sham VeNS

Sham Comparator group

Description:

The sham device looks identical to the active device and interacts with the app in a similar manner to the active device. It will apply some stimulation to a user for a limited period of time (30 seconds), before tapering down to zero over a further 20 seconds, thus creating the impression of an active device. The device will be placed on the head in a manner analogous to headphones with hydrogel electrodes placed over the mastoid processes. Participants will be advised to use the device at home for 30 minutes per day.

Treatment:

Device: Sham device